Archive for July, 2018

London: An Australian company has won unprecedented US approval for a new drug to treat the second most common preventable cause of blindness in the world.

In the process, Medicines Development for Global Health, based in Melbourne, became the first not-for-profit company in the world to register a medicine with the US Food and Drug Administration.

Mark Sullivan, managing director of Medicines Development for Global Health.

Photo: Supplied

The World Health Organisation has been calling for better treatments for river blindness for more than a decade, but because the medicine would be mostly used by those in poverty-stricken countries, there has been no financial incentive for drug companies to develop new treatments. The current treatment is 20 years old.

River blindness is caused by parasitic worms and spread by black flies. It affects the skin and eyes and is prevalent in sub-Saharan Africa.

In a double-win for Medicines Development for Global Health, it has also won a highly sought after voucher designed to financially reward companies that develop drugs for neglected diseases.

Managing director Mark Sullivan said while FDA approval for the company’s drug, moxidectin, was a “momentous achievement” for any pharma company, it was “a particularly rare and exciting event” for those trying to treat neglected diseases.

The FDA gave its approval for the treatment, which is swallowed as a tablet, in June after the application was submitted in October 2017.

Mr Sullivan established the Melbourne-based not-for-profit company in 2005 with the sole purpose of filling the gap left by the big pharmaceutical companies by developing medicines that were based on need for treatment rather than the patients’ ability to afford them.

Medicines Development for Global Health has been working for five years on the development of the drug and is now planning to develop moxidectin as a new treatment for scabies, a common problem in Indigenous communities.

Priority review voucher

The company has also won a priority review voucher under a scheme set up in 2007 to create a financial incentive to reward drug makers willing to spend the time and money developing treatments for the some of the world’s most neglected diseases. The scheme creates a market for making new drugs that the private market was not filling itself.

Under the scheme, a company that wins a voucher gets a fast track through the FDA for consideration of its next new drug, even if it’s a treatment that would have a commercial return. This gives it a head-start over its rivals.

Crucially, a company can also on-sell the voucher to a bigger company willing to pay anywhere between $US100 million and $300 million for the right to almost halve the approval time.

Because Medicines Development for Global Health is a not-for-profit, its proceeds from drug sales and the voucher will be reinvested in the company to develop new drugs & medications for other neglected diseases.

“Our plan is to sell the voucher and use the funds to support further development of moxidectin for other neglected diseases but also to expand our portfolio into other medicines and vaccines,” Mr Sullivan said.

Professor David Ridely from Duke University authored the scheme and said Medicines Development for Global Health was a textbook example of how he envisaged the program would work.

“I’m delighted that the voucher program is playing a role in treating patients with river blindness, and one day eliminating the disease,” he said.

Mr Sullivan said the development of moxidectin could not have been possible without a $US13 million co-investment from the Global Health Investment Fund, which is the social impact investment fund initially put together by the Bill and Melinda Gates Foundation.

”We believe moxidectin may play a pivotal role in eventually eradicating river blindness, and look forward to working with MDGH and others in making this happen,” Curt LaBelle, managing partner at the investment fund, said.

Color-enhanced Scanning Electron Micrograph (SEM) of Onchocerca volvulus, image of a female worm with microfilaria. O. volvulus is a nematode that causes onchocerciasis, or “river blindness,” mostly in Africa. Long-term corneal inflammation, or keratitis, leads to thickening of the corneal stroma which ultimately leads to blindness.

The Food and Drug Administration (FDA) has approved moxidectin for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients ≥12 years of age.

Moxidectin, a macrocyclic lactone, is an anthelmintic drug that selectively binds to the parasite’s glutamate-gated chloride ion channels. It is active against O. volvulus microfilariae but it does not kill adult O. volvulus parasites. The tropical disease spreads from person to person via black flies that breed near rivers in South and Central America, sub-Saharan Africa and Yemen

1 in 2 men and 1 in 3 women will develop cancer in their lifetimes. This saddening reality is made worse when it is acknowledged that modern methods of ‘treating’ the disease are often ineffective and only make the symptoms of the disease far worse. In fact, according to one Berkeley doctor, Dr. Hardin B. Jones, chemotherapy doesn’t work 97% of the time.

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In the eye-opening video above, Dr. Hardin B. Jones, a former professor of medical physics and physiology at the University of California, Berkeley, discusses how ‘leading edge’ cancer treatment is a sham.

Studied life expectancy of patients for over 25 years

He has personally studied the life expectancy of patients for more than 25 years and has come to the conclusion that chemotherapy does more harm than good. The bone-chilling realization prompted Dr. Jones to speak out against the billion-dollar cancer industry.

“People who refused chemotherapy treatment live on average 12 and a half years longer than people who are undergoing chemotherapy,” said Dr. Jones of his study, which was published in the New York Academy of Science.

“People who accepted chemotherapy die within three years of diagnosis, a large number dies immediately after a few weeks.”

According to the physician, the only reason doctors prescribe chemotherapy is because they make money from it. Such an accusation doesn’t seem unreasonable, as cancer

Patients rejecting conventional therapy live 4x longer

“Patients with breast cancer who reject conventional therapy live four times longer than those who follow the system. So this is something that you will not hear in the mass media, which will continue the myth…”

Despite the fact that the United States spends more on healthcare than any other high-income nation in the world, diseases of affluence continue to increase in prevalence, resulting in a shorter life expectancy.

Perhaps this is because mainstream media and the allopathic healthcare system don’t teach about the importance of preventative medicine. Eating a healthy diet, engaging in exercise, thinking positive thoughts, reducing stress, and enjoying the company of others – or habits that bring joy – are all proven to improve longevity and happiness.

As it is, there is no money in a healthy population, which is why fast food joints and pharmaceutical industries thrive in America. Hopefully, Dr. Jones’ efforts will inspire people to seek out alternative options if they or someone they know develops the debilitating disease.

Pride of Barbados is a small evergreen perennial shrub or tree, from the West Indies, 10 – 15 feet high with alternate, bipinnate leaves. The stem and branches are armed with spines. The red, orange, yellow and pink flowers grow at the end of the prickly branches. This small, graceful tree flowers throughout the year and is a beautiful garden plant. Pride of Barbados has beautiful bowl – shaped flowers in the colors red, orange, orange – red and yellow. The yellow variety is often called yellow bird of paradise.

The fruits are legumes, 3 – 4″ long; when ripe they split open and release the brown bean. The variety of pride of Barbados with red flowers is also called red bird of paradise, while the yellow species is called phoenix bird of paradise. Closely related is the Yellow bird of paradise (Caesalpinnia gilliesii) which has yellow flowers with long red stamens.

*** Suriname’s traditional medicine The leaves are purgative and used against kidney stones, malarial fever and bronchitis.

Great news for mangosteen lovers and those following the quest to find novel anti-cancer medicines derived from plants! We just received this report from our friends over at The Eden Prescription: In a new study published in Molecular Cancer (an open-access, peer-reviewed journal) alpha-mangostin, a substance derived from mangosteen pericarp, was shown to kill up to 99% of human breast cancer cells in vitro.*

What was particularly interesting about this study was that the researchers gained a deeper understanding of the mechanism of action of the mangosteen-derived substance. Alpha-mangostin was reported to block Fatty Acid Synthase – which disrupts the cancer cells’ ability to make fatty acids – without which they die. [1]

It appears that numerous cancer cell types require Fatty Acid Synthase for their survival, which may be the reason why mangostin has received much attention recently; it has also been found deadly also to prostate, liver, colon, and pancreatic cancers as well as leukemia.

Mangosteen (Garcinia mangostana) is an amazing, delicious tropical fruit – one of my favorites in fact – and was originally native to Thailand. Don’t be fooled by the name, it does not look or taste like a mango. Mangosteen has a thick, pithy casing (pericarp) which is easily broken or cut open to reveal the white, fleshy part inside that is eaten. Mangosteen is also considered potentially valuable with weight loss, inflammation, heart disease and diabetes! However it is the pericarp that may have the strongest medicinal qualities. For centuries, people in Southeast Asia have used dried mangosteen pericarp as antiseptic, anti-inflammatory, anti-parasitic, antipyretic, analgesic, and as a treatment for rashes. [2]

Tests like the study mentioned are the first step in the development and study of new medicines. It’s a long way before we can say for certain that mangosteen will have a direct anti-cancer action in humans – and in this study the beneficial substance was in the pericarp (the pithy case). However there have now been several promising studies on mangosteen extracts – including a 2013 study in which alpha-mangostin significantly suppressed tumor growth and reduced lymph node metastasis in mammary cancer in mice; leading researchers to conclude that “Mangosteen extracts appear to, in fact, have chemopreventive qualities and might prove useful as adjunctive and/or complementary alternative treatments in human breast cancer.” [2]

Mangosteen pericarp is available in supplement form.

* “In vitro” (literally “in glass”) is a scientific term used to denote that the test was done on isolated cell cultures in laboratory glassware, as opposed to in living creatures (“In vivo”).